Physiological Umbilical Cord Clamping in Patients With Congenital Diaphragmatic Hernia. Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Umbilical Cord Clamping
- Sponsor
- Hospital JP Garrahan
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- complete delivery according group
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
Congenital diaphragmatic hernia (CDH) is a malformation that affects 1 in every 3000 newborns. The diaphragm does not complete its closure during embryogenesis, which allows the abdominal organs to herniate into the thoracic cavity altering lung development. The lungs of patients with CDH are small, with a decreased surface area for gas exchange and developmental impair of the pulmonary vasculature, resulting in respiratory failure and pulmonary hypertension shortly after birth. When clamping the umbilical cord, a large part of the preload is abruptly excluded, generating an increase in vascular resistance, which in turn increase the afterload, resulting in a decrease in cardiac output. The output is restored by decreasing vascular resistance in pulmonary circuit after lung aeration upon receiving the preload of the right atrium, increasing pulmonary flow and thus sustaining the preload of the left ventricle. If pulmonary aeration occurs before clamping the umbilical cord, the pulmonary blood flow increases before placenta flow is lost, thus avoiding a decrease in cardiac output. This modality has been called physiological base cord clamping (PFC). The hypothesis is that PFC once ventilation has been established could prevent hypoxia and improve cardiac output in newborns with CDH and secondarily improve their hemodynamic parameters, stabilizing gas exchange and pulmonary hypertension during the first 24 hours of birth.
Detailed Description
* Type of study: Randomized clinical trial * Primary objective: To establish the effectiveness of PFC in reducing hypoxia and improving cardiac output compared to immediate postintubation clamping in newborns with CDH. To establish the safety and feasibility of PFC after pulmonary recruitment achieved post intubation. * Secondary objectives: describe the evolution of patients with CDH 24 hours after birth under pre-established conditions. Relate prenatal indices to the subsequent evolution of these patients. Describe maternal evolution and postpartum complications. * Population: Patients who attend the Fetal Diagnosis and Treatment program of Garrahan Children's Hospital and undergo prenatal diagnosis of CDH are possible candidates. The study will be carried out in the Neonatal Intensive Care Unit of said hospital. * Scope of the study: Garrahan Children's Hospital is a level 3 B pediatric hospital and national referral center located in Autonomous City of Buenos Aires, Argentina. Center that receives neonates with CDH referred from all over the country as well as from other countries in the region and carries out the relevant training for equal reception. * Block randomization: will be carried out on the same day, 2 hours before entering the delivery room * Intervention: Immediately after birth, the newborn will be placed on a mobile table, made to received these patients in the delivery room, at the level of the mother's womb, leaving the umbilical cord intact, intubated and gently ventilated (positive inspiration pressure (PIM) 15/25 - positive end expiratory pressure (PEEP)4 - fraction of inspired oxygen inspired oxygen fraction (FiO2) 50%), until saturation \>85% and heart rate (HR) \>100 or 10 timed minutes pass, whichever occurs first, the umbilical cord will be clamped and continued with the usual reception steps in accordance with the unit´s CDH reception protocol. * Sample size: To calculate the sample size, a prevalence of hemodynamic alterations of 60% was considered in the first 24 hours of life of patients with CDH, following unit statistics and the aforementioned bibliography. The estimated sample size with a relative reduction of 50%: reduction from 60% to 30% of hemodynamic alterations - Power of 80% - Two-tailed test - alpha 5%. 40 patients required in each branch.
Investigators
Mariela Jozefkowicz
Principal Investigator
Hospital JP Garrahan
Eligibility Criteria
Inclusion Criteria
- •Prenatal diagnosis of congenital diaphragmatic hernia
- •gestational age \>34 weeks
- •Informed consent signed by the patient's parents
Exclusion Criteria
- •Multiple gestation
- •Major malformation or fetal genetic anomaly diagnosed in the prenatal stage
- •Emergency cesarean section or maternal condition that prevents the approach
- •Lack of informed consent
Outcomes
Primary Outcomes
complete delivery according group
Time Frame: delivery
Complete the protocol in the delivery room pre-established according to randomization (yes/no)
Hemodynamic deterioration in the first 24 hours of life
Time Frame: 24 hours of life
Hemodynamic deterioration in the first 24 hours of life (meeting 3 of 4 of the following criteria or entry to extracorporeal membrane oxygenation (ECMO) or Death). 1. Pre/post ductal saturation difference \>10% 2. Oxygenation index (IO) \>20 3. mean arterial pressure \< Percentile 50 or inotrope requirement 4. Lactic acid \>3 mmol/l
Secondary Outcomes
- Intubation time(From delivery to intubation)
- Gestational age at diagnosis(1st day of life)
- Cord clamping time(from delivery to cord clamping)
- Time to reach heart rate (HR) >100(from delivery to 30 minutes of life)
- Mother arterial tension after delivery(10 minutes after delivery)
- Oxygenation on the first day(2 - 4 hours and 24 hours of life)
- PH value on the first day(6 and 24 hours of life)
- lung volumen(from 26 to 32 weeks of gestational age)
- liver in thorax(from 26 to 32 weeks of gestational age)
- Cord lactic acid value(inmediatly after cord clampping)
- near-infrared spectroscopy (Nirs) on the first day(2 - 4 hours and 24 hours of life)
- cardiac malformations(6 hours of life)
- Mcgoon(from 26 to 32 weeks of gestational age)
- Advance resuscitation need on delivery room(from delivery to 30 minutes of life)
- Arterial pressure at 10 minutes(10 minutes of life)
- Uterotonic use(30 minutes after delivery)
- Evolution of patient inotropes required(2 - 4 hours and 24 hours of life)
- ventilation requirements on the first day(2 - 4 hours and 24 hours of life)
- Oxygenation index (OI) on the first day(2 - 4 hours and 24 hours of life)
- B natriuretic peptide (BNP) on the first day(24 hours of life)
- Admission to ECMO(through study completion, an average of 1 year)
- Lung heart rate index observed/expected LHR O/E(from 26 to 32 weeks of gestational age)
- stomach herniation(from 26 to 32 weeks of gestational age)
- maternal hematocrit(1 day before delivery)
- Time to reach saturation (SAT) >85%(from delivery to 30 minutes of life)
- Evolution of patient Blood preassure (BP)(2 - 4 hours and 24 hours of life)
- Mortality(through study completion, an average of 1 year)
- Cord PH value(inmediatly after cord clampping)
- saturation at 10 minutes(10 minutes of life)
- placenta abruption(30 minutes of life)
- Inhaled nitric oxide (NOi) requirement(2 - 4 hours and 24 hours of life)